Tracking health factors in pregnant women and their children
Early Tracking of Childhood Health Determinants Study
This study looks at how the health and lifestyle of pregnant women from American Indian/Alaska Native and Hispanic backgrounds affect their children's growth and risk of obesity as they grow up.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 1 Day to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Phoenix, Arizona) |
| Trial ID | NCT03481829 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a longitudinal cohort of mother-child pairs among American Indian/Alaska Native and Hispanic populations to investigate how maternal health, lifestyle, and environmental factors influence childhood obesity and metabolic risks. Pregnant women will participate in multiple visits during and after pregnancy, while their children will be monitored for growth and health outcomes in their early years. The study focuses on understanding the associations between maternal risk factors and child development from birth through adolescence.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 18 and older who identify as American Indian or Hispanic.
Not a fit: Patients who are incarcerated or unable to consent, or those with non-viable pregnancies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved strategies for preventing obesity and related health issues in children.
How similar studies have performed: Other studies have shown success in examining maternal health impacts on child development, making this approach both relevant and promising.
Eligibility criteria
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Pregnant women aged 18 years or older (pregnancy confirmed by urine or serum pregnancy test, or ultrasound examination) 2. American Indian or Hispanic by self-report 3. Agree to continue with research study participation (both mother and their offspring), for at least 3 years after delivery. In case where a pregnant mother is carrying multiple fetuses (multiple pregnancy), she will be eligible to participate in this study and all her live newborns, as a result of that pregnancy, will be eligible for participation in this study. Mothers will also be eligible to participate with any consecutive pregnancies. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Women who are incarcerated or are unable to consent. 2. Women whose fetus is not viable or are not planning to continue the pregnancy.
Where this trial is running
Phoenix, Arizona
- NIDDK, Phoenix — Phoenix, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Madhumita Sinha, M.D. — National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study coordinator: Madhumita Sinha, M.D.
- Email: madhumita.sinha@nih.gov
- Phone: (301) 451-6237
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.